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Medication Errors Related to IND Labels Discussed

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FDA and the Reagan-Udall Foundation hold a two-day meeting on the role of investigational drug labels in medication errors.

Guide on Trial Data Sets for NASH Drugs

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FDA releases a guidance entitled Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic No...

Coordinated National Trial Infrastructure Needed: Gottlieb

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Former FDA commissioner Scott Gottlieb says the nation needs a coordinated national clinical trial infrastructure for use during p...

Use Risk Assessments on Trial Monitoring Decisions: FDA

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FDA revises its guidance on remote monitoring of clinical trials conducted during the Covid emergency and whether onsite monitorin...

2 New MAPPs Out

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CDER issues Manuals of Policies and Procedures on scientific interest groups and data standards.

MiRus Lumbar Interbody Device Cleared

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FDA clears a MiRus 510(k) for its IO Expandable Lumbar Interbody device for use in posterior and transforaminal fusion procedures.

UCB Gets Expanded Pediatric Indication for Briviact

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FDA approves a UCB expanded indication for Briviact (brivaracetam) tablets, oral solution, and injection to treat partial-onset se...

Anixa Gains IND Approval of CAR-T for Ovarian Cancer

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FDA approves an Anixa Biosciences IND for its CAR-T (Chimeric Antigen Receptor-T cell) therapy and its use in treating ovarian can...

Guide Revised on Trials Conducted During Covid

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FDA revises its guidance entitled Conduct of Clinical Trials of Medical Products During the Covid-19 Public Health Emergency.

De Novo Granted for Smart Knee Replacement

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FDA grants a de novo authorization to Zimmer Biomet and Canary Medical for their tibial extension for Persona IQ, the first smart ...